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    Diversity Manager - London, United Kingdom - Sobi, Inc

    Sobi, Inc
    Sobi, Inc London, United Kingdom

    2 weeks ago

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    Description

    We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease.

    The CMC Dossier Manager plays a crucial role in developing the technical eCTD sections to support Regulatory CMC dossier applications.

    Additionally, they coordinate timelines, virtual documents, and the generation of the Quality module.
    Lead and supervise dossier authoring activities for early and late-stage projects with limited guidance from the manager.
    Identify areas for business improvement and support the implementation of enhancements under managerial supervision.
    Interface directly with CMC/Tech team members, Regulatory bodies, external service providers, and internal stakeholders with autonomy.
    Manage several complex projects with accelerated or standard priority, challenging the status quo and driving innovative approaches.

    Strong background in Small Molecules, Technical Dossier Writing, Global (FDA, EU, Latin America, China, Russia) Management of Post Approval Changes and Development.

    PhD with Post-doc experience and 8+ years of relevant experience OR University degree with 12+ years of relevant experience.

    Competitive compensation for your work
    Emphasis on work/life balance
    Opportunities for professional growth
    Diversity and Inclusion
    Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

    With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we're ready to take on the world's diseases, ailments and adversity.

    We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

    This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

    By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.

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